We live in a world where speed is vital to success. Patients and consumers expect products to be of good quality and available when needed. Therefore, companies must oblige in the expected [...]
Blog Home TAG: 21 CFR Part 11
In Manufacturing Industries, Document Management, eMDR, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance ManagementPosted
With more modern-day compliance enforcement, life science manufacturers and distributors are opting to digitize manual, paper processes with electronic transactions. Electronic records and [...]
In Archives, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk ManagementPosted
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both [...]
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